Rationale and design of the multinational observational study assessing insulin use: the MOSAIc study

BMC Endocrine Disorders

Study Protocol

Niteesh K Choudhry¹  Jennifer M Polinski¹  John D Seeger¹  William H Shrank¹  Anthony Zagar²  Bradley H Curtis² 

[1] Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital, 1620 Tremont Street, Suite 3030, Boston, MA, USA;Harvard Medical School, Boston, MA, USA;Eli Lilly and Company, Indianapolis, IN, USA;

关键词: Type 2 diabetes;    Insulin;    Treatment;    Health outcomes;    Epidemiology;   

DOI  :  10.1186/1472-6823-12-20

 received in 2012-05-04, accepted in 2012-09-17,  发布年份 2012

来源: Springer

【 摘 要 】

BackgroundAlthough consensus guidelines recommend insulin progression among patients with type 2 diabetes (T2DM) who fail to meet glycemic targets over time, many fewer patients are progressed than may benefit. We describe the rationale and design of the MOSAIc (Multinational Observational Study Assessing Insulin use) study, a multinational observational cohort study to identify patient-, physician, and health care environment-based factors associated with insulin progression for patients with T2DM in real-world practice.Methods/designWe will enroll 4,500 patients with T2DM taking initial insulin therapy for ≥3 months across 175 physician practice sites in 18 countries. Extensive demographic, clinical, and psychosocial data at the patient and physician level and practice site characteristics will be collected at baseline and regular intervals during a 24-month follow-up period. We will use a multivariable logistic regression model to identify predictors of insulin progression and highlight potential opportunities for health behavior intervention to improve insulin progression rates. Secondary outcomes include evaluating factors associated with glycemic control, hypoglycemia, and treatment adherence among patients who do and do not progress beyond their initial insulin therapy and exploring geographic heterogeneity in treatment.DiscussionPractice site and patient recruitment began in 2011 and baseline data will be available in late 2012. The MOSAIC study’s longitudinal observational design as well as the breadth and depth of data will be used to explore and quantify predictors of insulin progression and to identify potential opportunities for health behavior intervention in order to improve T2DM treatment and clinical outcomes.

【 授权许可】

CC BY   
© Polinski et al.; licensee BioMed Central Ltd. 2012